Medical Advances

At Emory, clinical trials are at the core of our mission and we are proud to offer them to our patients. Groundbreaking scientific advances and medical treatments available today have been made possible because of volunteer participation in clinical trials and research.

In fact, one of the thousands of clinical trials conducted at Emory was just identified as one of the 15 top international clinical trials ever published for physical therapy and rehabilitation.

The EXCITE (Extremity Constraint-Induced Therapy Evaluation) trial, led by Emory University’s Steven Wolf, PhD, PT, professor of rehabilitation medicine at Emory University, was created to teach stroke patients to use their stroke-affected arm rather than their “good” arm. Conducted almost a decade ago, the clinical trial was found to have a significant impact in stroke rehabilitation, which set the stage for many future trials.

Each year, more than 795,000 people in the United States suffer from a stroke and many stroke survivors experience partial paralysis on one side of the body. The EXCITE trial enrolled 222 patients who had suffered a stroke, predominantly an ischemic stroke, within the previous three to nine months.

During the trial, participant’s less-impaired hand was restrained and/or immobilized by placing a mitt around the “good” arm in an effort to encourage use of the affected extremity. Participants engaged in daily repetitive tasks and behavioral therapy sessions, which included training in tasks such as opening a lock, turning a doorknob or pouring a drink. Only use of the affected arm was allowed during exercise.

“Often, stroke rehabilitation focuses on teaching patients how to better rely on their stronger limbs, even if they retain some use in the impaired limbs, creating a learned disuse,” says Wolf. “This trial was just the opposite and focused on the impaired limb, which proved to be a valuable form of rehabilitation. We are so pleased and honored that this clinical trial has been found to be a top 15 trial amongst an international jury of experts.”

Wolf, and other Emory University researchers partaking in the national trial, studied participants to determine if the intervention improved motor function, as compared to no therapy at all. Patients were evaluated using the Wolf Motor Function Test (named after Wolf), which is a measure of laboratory time, strength-based ability and quality of movement.

Research investigators found that over the course of a year from the beginning of therapy, the group undergoing constraint-induced therapy showed greater improvements than the control group in regaining function.

“Results showed that constraint-induced movement therapy produced statistically significant and clinically relevant improvements in arm motor function that persisted for at least one year at follow-up,” says Wolf. “This trial was the first large multi-center, randomized controlled trial in stroke rehabilitation that lay the ground work for many other trials to follow.”

The EXCITE trial was funded by the National Institutes of Health from 2000-2005 and the results were published in JAMA in 2006. For the past 15 years, PEDro, a database located and supported within the George Institute for Global Health in Australia, has reviewed clinical trials, guidelines and reviews of work related to rehabilitation and physical therapy. During that time period, around 28,000 trials and manuscripts dating back as far as 1929 were reviewed. The free database is used by thousands of physiotherapists and others interested in rehabilitation from more than 200 countries. Out of the 15 trials highlighted by PEDro, only two were clinical trials based in the U.S.

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Fertility preservation – or, as it’s popularly known, egg freezing — has recently received a burst in media attention. Since the American Society of Reproductive Medicine (ASRM) endorsed oocyte (egg) cryopreservation (freezing) as no longer experimental in October of 2012, the options for women desiring to delay childbearing have expanded.

Who Should Consider Egg Freezing?

ASRM recommends oocyte cryopreservation for fertility preservation for specific indications, namely to preserve fertility potential prior to gonadotoxic treatment for cancer or other medical conditions, among women at risk for premature ovarian failure, and among women undergoing in vitro fertilization (IVF) who prefer not to freeze embryos. ASRM recommends thorough patient counseling prior to elective cryopreservation to defer childbearing for social reasons and specifically states that “data on the safety, efficacy, cost-effectiveness, and emotional risks of elective oocyte cryopreservation are insufficient to recommend elective oocyte cryopreservation.” While egg freezing is not universally recommended for all single women, the decision to freeze eggs may be a good option for certain women who have received thorough counseling from a reproductive endocrinologist.

What Does Egg Freezing Involve?

The process is very similar to IVF. Oocyte cryopreservation requires daily injectable medications over a 2-3 week period to first suppress the brain’s signal to the ovary, and then to stimulate the ovary to “superovulate” to recruit 10-20 eggs, if possible. During the approximately 10 days of stimulation, the patient comes to the clinic around 5 times for a blood test and pelvic ultrasound to monitor the ovaries’ response to the medications. Once the eggs are ready, the patient undergoes an egg retrieval, which is a 30 minute outpatient procedure. For IVF, the eggs are fertilized with sperm, and then an embryo is transferred to the uterus. For egg freezing, the eggs are frozen after the retrieval.

What is the Chance of Successful Pregnancy after Egg Freezing?

As with all assisted reproductive technology procedures, the success of fertility treatments correlates to a woman’s age at the time of treatment. In general, the younger the woman is, the better chance she has of conceiving. Pregnancy outcomes of IVF vary by clinic and can be found on the CDC website. At the Emory Reproductive Center, we’re proud to report that our rates consistently exceed the national average. Pregnancy outcomes after egg freezing are a little less predictable, because the technology to rapidly freeze eggs is relatively new. In general, trials to date suggest that over 90% of frozen eggs will survive the thawing process and that pregnancy rates should be comparable to those using fresh eggs. Every 6 to 7 frozen eggs should allow for one embryo transfer with a chance of pregnancy dependent on the female partner’s age at the time of egg freezing. This chance can be as high as 60 to 70% in a female who froze her eggs when she was younger than 35 years old; however, the chance of pregnancy decreases with advancing female age at the time of freezing.

Does the Emory Reproductive Center Offer Egg Freezing?

Yes! We routinely offer and perform oocyte cryopreservation for fertility preservation due to medical conditions and social reasons. We would be happy to discuss your personal situation with you in more detail. To schedule a new patient visit, please call (404) 778-3401, and select option 1 for the Emory Reproductive Center.

What is the Cost of Egg Freezing?

The out-of-pocket cost for oocyte cryopreservation varies based on your insurance. In general, the cost of the ovarian stimulation and monitoring, egg retrieval, and freezing is approximately $4,000. The cost of medications can vary, depending upon the patient’s dose and responsiveness to them. Additionally, if a patient later chooses to thaw and fertilize their eggs to undergo an embryo transfer, they will incur the cost of those procedures, as well, which can currently run about $5,000.

About Dr. Jennifer Kawwass

Jennifer Kawwass, MD, is an Assistant Professor in the Department of Gynecology and Obstetrics at Emory University School of Medicine and a Guest Researcher at the Centers for Disease Control and Prevention where she is a member of the Assisted Reproductive Technology (ART) Team. Dr. Kawwass sees patients at the Emory Reproductive Center at Emory University Hospital Midtown where she serves as the Donor Egg Program Director. Her clinical interests include infertility, in vitro fertilization, functional hypothalamic amenorrhea, and fertility preservation. Dr. Kawwass is originally from Virginia Beach. She attended Davidson College, University of Virginia Medical School, and subsequently completed both her Ob/Gyn Residency and REI Fellowship at Emory University School of Medicine. She enjoys spending time with her husband and two young children, running, and visiting her family at the beach.

At Emory Healthcare, we are proud to sponsor clinical trials and offer the opportunity for our patients to participate in them. Currently there are more than 1,000 clinical trials offered throughout our health care system. As one of the nation’s leading academic medical systems, our involvement in clinical trials sets us apart from other health care organizations. Access to advanced resources and technology allows our care team to provide patients with the most effective and progressive treatments. It’s only once these treatments are approved that they’re made available elsewhere.

Medical advances and improvements to patient care have been made possible by clinical trials and the participation of volunteers. Below are answers to frequently asked questions you may have about clinical trials.

Q. What is a clinical trial?

A. A clinical trial is a form of research that uses human volunteers (called participants) to help answer specific questions about new ways to prevent, diagnose and treat diseases. Clinical trials are extremely important because they allow researchers to work with patients suffering from the exact condition they are trying to treat.

Q. What types of clinical trials are available at Emory?

A. There are several forms of clinical trials. Some trials test new drugs, procedures or other treatments, and others look for better ways to prevent diseases in people who have either never had a disease or are trying to keep one from coming back. Some trials are used to develop better ways to diagnose a particular disease or condition while other trials help find ways to improve the care and quality of life of people with long-term illnesses.

Q. What do the different phases of trials mean?

A. Clinical trials take place in “phases,” and each phase helps researchers answer specific questions.

Phase I Clinical Trials: These trials are used to test brand new drugs, devices or procedures to find out how safe they are and identify possible side effects. They usually involve 20 to 80 people.

Phase II Clinical Trials: These trials are used to further evaluate the effectiveness and safety of a drug, device or procedure. The researchers keep track of any medical benefits, as well as side effects. They usually involve 100 to 300 people.

Phase III Clinical Trials: These trials compare a new treatment or procedure with a standard old treatment or procedure to figure out which works best. Evaluation of side effects and effectiveness continues. They usually involve 1,000 to 8,000 people.

Phase IV Clinical Trials: Once a drug or procedure is approved by the U.S. Food and Drug Administration (FDA) and made available to the public, researchers continue to study its safety to figure out the best use of the new treatment.

Q. Who can participate in clinical trials?

A. Both people in good health and people with certain diseases or conditions participate in clinical trials. People participate in trials to help researchers find better treatments, or to receive care or treatment only available as part of a clinical trial.

Q. How does clinical research make a difference?

A. Clinical research helps us learn about the safety and effectiveness of all drugs, procedures and other
treatments. Medical advances like new drugs and surgical procedures are made possible because of clinical trials and the voluntary participation of individuals.

At Emory, we’re conducting clinical trials and research to make a difference in people’s lives, here and now and for generations to come. While there are many benefits to participating in clinical trials, there can also be risks, which is why it is important to speak with a physician before deciding to participate. For more information on clinical trials at Emory, please view a complete list of our Frequently Asked Questions. If you have additional questions, visit our clinical trials website or call 404-778-7777.

Congratulations to Emory University Hospital who recently joined an elite group of fewer than 30 centers nationwide with its Comprehensive Stroke Center Certification from The Joint Commission and the American Heart Association/American Stroke Association! Emory University Hospital is the only hospital in metropolitan Atlanta to earn this designation and just one of two in Georgia. Comprehensive Stroke Center Certification recognizes only those hospitals that have state-of-the-art infrastructure, staff and training to receive and treat patients with the most complex strokes. Emory University Hospital underwent a rigorous onsite review by The Joint Commission in February 2013.

So, what does this all mean for you? It means that our Emory University Hospital stroke team provides advanced care, including:

The Emory Stroke Center team provides 24/7 coverage and receives early warning about a patient arriving with stroke symptoms. This early notification ensures rapid assessment and stabilization, and an immediate CT brain scan to establish onset time and to determine eligibility for various treatment options.

Stroke is a disease that affects the arteries leading to and within the brain. According to the American Stroke Association, stroke is the number four cause of death and a leading cause of disability in the United States. Immediate treatment is essential when someone is having a stroke to reduce the effects and potential for permanent disability. Not close to Emory when an emergency strikes? Nearly half of our patients are transferred from other hospitals, and most of those arrive via helicopter. The Emory Healthcare system also has three Primary Stroke Centers accredited by The Joint Commission, including Emory University Hospital Midtown, Emory Johns Creek Hospital and Saint Joseph’s Hospital.

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Last year, Emory Johns Creek Hospital purchased a da Vinci® Surgical System and took robotic-assisted surgery at the hospital to a whole new level. The da Vinci® SI, or Streamlined Integrated, is the most technologically advanced system available on the market. It allows surgeons to use tiny robotic instruments they control in real-time to perform minimally invasive procedures requiring only small incisions.

Amy Fischer, Director of Surgical Services for the hospital, says robotic surgery offers patients “a much quicker recovery with virtually no scarring.” It can also simplify more complex surgeries. “Patients who would normally be down and out for six weeks are up and going in a matter of two to three weeks,” says Fischer. “They use less pain medication, and there’s less risk of infection.”

Gynecological surgeons were the first to use the system, to perform hysterectomies and remove fibroids with less pain and blood loss and, in many cases, preserving fertility.

“We hit the ground running and have really just soared with the program,” Fischer says. “In a matter of a year we have grown to offering not just GYN surgery, but general surgery, GYN-Oncology, colorectal and bariatrics.”

Bariatric surgeons are now also using robotic technology to perform gastric bypass and sleeve gastrectomy for weight loss, and Emory Johns Creek Hospital was only the second in the Atlanta area to perform Single-SiteTM gallbladder surgery, a procedure that is now used nationwide. Using Single-SiteTM technology, a cholecystectomy can be performed in about one hour, with a typical hospital stay of less than 24 hours. Thanks to its success with the procedure, the hospital will soon be a case observation site.

Over the past year, more than 300 patients have benefited from the da Vinci® Surgical System. “We have a phenomenal team that has grown with the program,” Fischer says. “And we have had excellent patient outcomes.”

A surgical team at Emory Johns Creek Hospital performed their first single-site gallbladder surgery on Friday, April 27, 2012. During this minimally invasive laparoscopic procedure, the patient’s gallbladder was removed via a single small incision in the belly button. The team removed the gallbladder using Single-Site™ instruments on a da Vinci® System. This robotic surgical system, which is widely used in complex minimally invasive surgery, allowed the surgeons to remove the gallbladder through an incision of approximately one inch. Traditional robotic surgeries require three to five small incisions.

Potential benefits of Single-Site gallbladder surgery include virtually scarless results, minimal pain, low blood loss, fast recovery, a short hospital stay and high patient satisfaction. The surgery can be performed in about one hour, with a typical hospital stay of less than 24 hours.

During the procedure, the surgeon sits at a console, viewing a 3D, high-definition image of the patient’s anatomy, and uses controls below the viewer to move the da Vinci Robot’s arms and camera. The system translates the surgeon’s hand, wrist, and finger movements in real-time into the more precise movements of the tiny instruments inside the patient. Most people who require gallbladder removal are candidates for the robotic, single-incision surgery.

Dr. Christopher Hart, of Emory Johns Creek Surgery, PC, and medical director of the Atlanta Bariatric Center, is one of a small group of surgeons in the country who have received training in Single-Site gallbladder surgery, and Emory Johns Creek Hospital is one of only two hospitals in the state to perform the procedure. To learn more about this procedure, visit emoryjohnscreek.com/robotics.

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When the Urology Department of Emory Healthcare started offering no-scalpel, no-needle vasectomies as part of their men’s health treatment options, our ears perked up. Obviously, as the name implies, this type of vasectomy procedure allows doctors to forego the scalpel and needle combination used in traditional vasectomies, but what is used in their place? And what are the benefits? To get our questions answered, we went straight to the source, Emory’s own Dr. Wayland Hsiao, who is one of the surgeons performing the procedure. Our questions for Dr. Hsiao (and his answers) are below:

What exactly does it mean when we say no-scalpel, no-needle vasectomy? Can you describe the procedure?

A vasectomy is a procedure in which when the outflow of sperm through the vas deferens is interrupted to stop the outflow of sperm. It is a permanent form of male contraception. The procedure has no effect on sexual function. The no-scalpel vasectomy is a technique that allows us to perform the vasectomy through a puncture. The puncture is made in the scrotum and requires no suturing or stitches.

When compared to the conventional vasectomy, the primary difference is that the vas deferens tissues and blood vessels are spread aside from the surgical site rather than cut with a knife. This is less traumatic, and results in less pain and fewer postoperative complications. To numb the patient before the vasectomy, a Madajet injector is used. This is a tool that facilitates a highly pressurized lidocaine (anesthetic) to be sprayed on and through the scrotal skin to numb the skin and the underlying vas deferens. No needle is used in this anesthetic technique.

So, in terms of how the procedure is performed, what are the biggest differences?

We are able to replace the traditional scalpel with a specially design sharp clamp, which alleviates the need for an incision. The traditional incision is replaced by a small puncture hole which seals itself after the procedure. We also replace the needle with an anesthetic spray (diffused via the Madajet injector) that is applied to the scrotal skin and the vas deferens itself.

What are the benefits to no-scalpel, no-needle vasectomy?

Good question. There are several. With the no-scalpel vasectomy, there is less bleeding. In fact, the bleeding rate decreases from being seen in about 3% of patients down to 0.3%. In other words, there is 10 times lesser chance of bleeding. The infection rate after vasectomy is also decreased with the no-scalpel, no-needle technique. Infection is seen in 1.4% of patients with a traditional approach, while we only see infections inabout 0.1% of men undergoing the no-scalpel technique.

The bladeless vasectomy procedure is also faster, because the need for suturing is eliminated because there is no incision. The hole or puncture (2-3mm) created from the procedure will close up on its own.

Are there any risks associated with this procedure? If so, what are they?

The no-scalpel, no-needle vasectomy doesn’t come with any additional risks that we don’t already see with the standard vasectomy procedure, which include the risk of hematoma (with no-scalpel, this risk is significantly lowered to less than 0.5 %) and infection. As is true with all vasectomy procedures, the procedure is not guaranteed to be 100% effective. The general post-vasectomy failure rate is less than 0.5 % (1 in 500 short term failure; 1 in 4500 long term failure).

How long does the no-scalpel, no-needle vasectomy take?

The procedure takes about 30 minutes.

What can patients expect after the no-scalpel, no-needle vasectomy?

Patients can expect to experience swelling of scrotom for 2-3 days and bruising for up to a week. They might also experience a feeling of heaviness or dragging testes for 2-3 weeks.

How long is the recovery? How soon can I have sex post-procedure?

To achieve full recovery, patients should wait approximately 2 weeks after the procedure before participating in intercourse, but men should consult with their physician for guidance here.

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